FDA Product Code DWP: Dilator, Vessel, Surgical
Leading manufacturers include American Edwards Laboratories, Shiley, Inc. and Geomed Medizin-Technik GmbH & Co..
20
Total
20
Cleared
116d
Avg days
1979
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Dilator, Vessel, Surgical Devices (Product Code DWP)
20 devices
Cleared
Apr 20, 2023
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
Fehling Surgical Instruments, Inc.
Cardiovascular
381d
Cleared
Sep 03, 2019
Geomed Vascular Dilators
Geomed Medizin-Technik GmbH & Co.
Cardiovascular
265d
Cleared
Jul 02, 1991
LAPAROSCOPIC VESSEL ARTICULATOR
United States Endoscopy Group, Inc.
Cardiovascular
89d
Cleared
Oct 16, 1990
FOGARTY VESSEL CALIBRATOR
Baxter Healthcare Corp
Cardiovascular
154d
Cleared
Aug 31, 1983
VESSEL DILATOR
Abbott Laboratories
Cardiovascular
29d
Cleared
Oct 04, 1982
REUSABLE FOGARTY FLEXIBLE CALIBRATOR
American Edwards Laboratories
Cardiovascular
31d
Cleared
Nov 16, 1981
FOGARTY FLEXIBLE PROBE
American Edwards Laboratories
Cardiovascular
27d
Cleared
May 15, 1981
FOGARTY FLEXIBLE CALIBRATOR
American Edwards Laboratories
Cardiovascular
42d
Cleared
Dec 04, 1979
BONCHEK-SHILEY VEIN DISTENTION SYSTEM
Shiley, Inc.
Cardiovascular
43d
Cleared
Jun 13, 1979
SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO
Shiley, Inc.
Cardiovascular
26d
About Product Code DWP - Regulatory Context
510(k) Submission Activity
20 total 510(k) submissions under product code DWP since 1979, with 20 receiving FDA clearance (average review time: 116 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.